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免疫检查点抑制剂相关免疫不良反应的住院率评估。

Assessment of hospitalization rates for immune-related adverse events with immune checkpoint inhibitors.

作者信息

Nice Laura, Bycroft Ryan, Wu Xiaoyong, Rai Shesh N, Figg Lindsay, Bhandari Shruti, Burd Megan

机构信息

Department of Pharmacy, University of Louisville Hospital, Louisville, KY, USA.

Biostatistics and Bioinformatics Facility, University of Louisville James Graham Brown Cancer Center, Louisville, KY, USA.

出版信息

J Oncol Pharm Pract. 2021 Oct;27(7):1736-1742. doi: 10.1177/1078155220968909. Epub 2020 Oct 25.

Abstract

INTRODUCTION

Immune checkpoint inhibitors (ICIs) have become the standard of care in many cancer types. As the number of patients receiving ICIs for various cancers continues to expand, patients and practitioners should be aware of potentially severe immune-related adverse events (irAEs). Despite reports of the incidence of grade 3/4 toxicities, the proportion of patients whose symptoms were clinically severe enough to warrant hospitalization for adverse event management is unknown.

METHODS

This single center, retrospective, observational study was designed to determine the impact of irAEs on patients and the hospital. Patients who started ICIs from May 2016 through May 2019 for melanoma or lung cancer were included. The primary outcome was incidence of hospitalization for irAE. Secondary outcomes included median length of hospitalization, time to onset of irAE, rates of hospitalization for irAE per each checkpoint inhibitor regimen, organ system affected, progression free survival, and overall survival.

RESULTS

Of 384 patients with melanoma or lung cancer, 27 (7%) were hospitalized at our institution for an irAE. The most common irAE leading to hospitalization was colitis for patients with melanoma and pneumonitis for patients with lung cancer. The median length of stay across all hospitalizations was 10 days. Twenty-five patients required the use of corticosteroids while hospitalized, while eight of these patients required second line irAE treatment. For the total patient population, 34.7% experienced a grade 1/2 irAE and 13.1% experienced a grade 3/4 irAE.

CONCLUSION

Our cohort of patients experienced similar rates irAEs as reported in clinical trials and published reports.

摘要

引言

免疫检查点抑制剂(ICIs)已成为多种癌症类型的标准治疗方法。随着接受ICIs治疗各种癌症的患者数量不断增加,患者和从业者应意识到潜在的严重免疫相关不良事件(irAEs)。尽管有关于3/4级毒性发生率的报告,但症状严重到足以因不良事件管理而住院的患者比例尚不清楚。

方法

本单中心、回顾性、观察性研究旨在确定irAEs对患者和医院的影响。纳入了2016年5月至2019年5月开始使用ICIs治疗黑色素瘤或肺癌的患者。主要结局是因irAE住院的发生率。次要结局包括住院中位时长、irAE发病时间、每种检查点抑制剂方案的irAE住院率、受影响的器官系统、无进展生存期和总生存期。

结果

在384例黑色素瘤或肺癌患者中,27例(7%)在我们机构因irAE住院。导致住院的最常见irAE是黑色素瘤患者的结肠炎和肺癌患者的肺炎。所有住院患者中位住院时长为10天。25例患者住院期间需要使用皮质类固醇,其中8例患者需要二线irAE治疗。在全部患者中,34.7%经历了1/2级irAE,13.1%经历了3/4级irAE。

结论

我们的患者队列经历的irAEs发生率与临床试验和已发表报告中报道的相似。

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